Effect of Nutritional Counseling on Health Outcomes in Female Workers Wih Obesity at Adam Malik Hospital

NCT06621589 | Completed DMC

• 1 other identifier: 1084/KEPK/USU/2024
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this quasi-experimental study is to determine whether nutritional counseling can improve health outcomes in female workers with obesity at Adam Malik Hospital in Medan. Specifically, the study aims to assess the impact of nutritional counseling on participants; anthropometric measurements, body composition, total cholesterol, blood glucose, uric acid levels, as well as on attitudes, and behavioral changes. The main questions it aims to answer are:

• What are the effects of nutritional counseling on anthropometric measurements, body composition, total cholesterol, blood glucose, uric acid levels?
• How does nutritional counseling affect attitudes toward healthy eating and changes in health behaviors? Researchers will compare the health metrics of participants before and after receiving nutritional counseling to evaluate its effectiveness. Participants will:
• Attend personalized nutritional counseling sessions over a period of 2 months.
• Complete assessments that include anthropometric measurements (weight, height, BMI), body composition analysis, and blood tests for total cholesterol, blood glucose, uric acid levels
• Fill out questionnaires to provide information on their attitudes, and health behaviors before and after the intervention. This study aims to provide insights into the benefits of nutritional counseling in improving various health outcomes among obese female employees.

Conditions

Obesity

Keywords

Nutritional Counseling; Obesity; Female Employees; Anthropometry; Body Composition; Lipid Profile; Uric Acid Levels; Blood Glucose; HbA1c; Quasi-Eksperimental Study; Adam Malik Hospital; Medan; Dietary Intervention

Outcome Measures

Primary Outcomes (12)

• Weight in Nutritional Counseling

  Weight will be measured using a calibrated body weight scale. Participants will be assessed barefoot, standing upright, and with pockets emptied. Measurements will be recorded to an accuracy of 0.1 kg. Weight will be measured twice: before and after counseling to evaluate changes. Outcome Measure: Weight (unit: kg)

  Baseline and 8-week after the intervention

• Height in Nutritional Counseling

  Height will be measured using a GEA SMIC ZT-120 scale stadiometer. Participants will be assessed barefoot, standing straight with their back, shoulders, buttocks, and heels against the wall. Measurements will be recorded to an accuracy of 0.1 cm. Height will be measured twice: before and after counseling to evaluate changes. Outcome Measure: Height (unit: cm)

  Baseline and 8-week after the intervention

• Body Mass index in Nutritional Counseling

  Body Mass Index (BMI) will be calculated using the formula BMI = weight (kg) / height (m²). Weight will be measured using a calibrated body weight scale and height using a GEA SMIC ZT-120 scale stadiometer. BMI will be calculated after obtaining both measurements, assessed twice: before and after counseling to evaluate changes. Outcome Measure: BMI (unit: kg/m²)

  Baseline and 8-week after the intervention

• Mid-Upper Arm Circumference (MUAC) in Nutritional Counseling

  Mid-Upper Arm Circumference (MUAC) will be measured using the SECA 201 measuring tape. Measurements will be taken at the midpoint between the acromion and olecranon processes of the non-dominant arm, following standard procedures. MUAC will be recorded before and after the nutritional counseling intervention to assess changes in muscle and fat tissue.

  Baseline and 8-week after the intervention

• Waist Circumference (WC) in Nutritional Counseling

  Waist Circumference (WC) will be measured using the SECA 201 measuring tape at the midpoint between the lowest rib and the iliac crest, following standard anthropometric guidelines. WC measurements will be taken before and after the nutritional counseling intervention to monitor changes in abdominal fat.

  Baseline and 8-week after the intervention

• Fat Free Mass Index in Nutritional Counseling

  Fat Free Mass Index (FFMI) will be calculated using the formula FFMI = fat free mass (kg) / height (m²). Fat free mass will be assessed using the bioelectrical impedance analysis (BIA) device, SECA 514. Participants will be prepared as per standard guidelines. FFMI will be measured before and after counseling to track changes. Outcome Measure: Fat Free Mass Index (unit: kg/m²)

  Baseline and 8-week after the intervention

• Fat Mass in Nutritional Counseling

  Fat Mass will be calculated using the bioelectrical impedance analysis (BIA) device, SECA 514. Participants will be prepared according to standard guidelines prior to measurement. Fat Mass (in kilograms) will be assessed before and after the nutritional counseling intervention to monitor changes in body composition.

  Baseline and 8-week after the intervention

• Skeletal Muscle Mass in Nutritional Counseling

  Skeletal Muscle Mass (SMM) will be measured using the bioelectrical impedance analysis (BIA) device, SECA 514. Participants will adhere to standard preparation procedures. SMM will be recorded in kilograms (kg) and assessed before and after counseling to monitor changes. Outcome Measure: Skeletal Muscle Mass (unit: kg)

  Baseline and 8-week after the intervention

• Visceral Adipose Tissue (VAT) in Nutritional Counseling

  Visceral Adipose Tissue (VAT) will be measured using the bioelectrical impedance analysis (BIA) device, SECA 514. Participants will follow standard preparation guidelines before the assessment. VAT will be evaluated before and after the nutritional counseling intervention to monitor changes in visceral fat levels.

  Baseline and 8-week after the intervention

• Uric Acid Levels in Nutritional Counseling

  Uric acid levels will be measured using the AutoCheck device, a point-of-care testing system. Blood samples will be collected via finger prick without the need for fasting. Measurements will be taken at baseline and 8 weeks after the nutritional counseling intervention to monitor changes in uric acid levels. Outcome Measure: Uric Acid (unit: mg/dL or μmol/L)

  Baseline and 8-week after the intervention

• Blood Glucose Levels in Nutritional Counseling

  Blood glucose levels will be measured using the AutoCheck device, a point-of-care testing system. Blood samples will be collected via finger prick after an overnight fast of at least 8 hours. Measurements will be taken at baseline and 8 weeks after the nutritional counseling intervention to monitor changes in glycemic control.

  Baseline and 8-week after the intervention

• Total Cholesterol in Nutritional Counseling

  Total cholesterol levels will be measured using the AutoCheck device, a point-of-care testing system. Blood samples will be collected via finger prick after an overnight fast of at least 8 hours. Measurements will be conducted at baseline and 8 weeks after the nutritional counseling intervention to monitor changes in lipid profile.

  Baseline and 8-week after the intervention

Secondary Outcomes (2)

• Attitude in Nutritional Counseling

  Baseline and 8 weeks after the intervention

• Behavioral Changes in Nutritional Counseling

  Baseline and 8-week after the intervention

Study Arms (1)

Nutritional Counseling Group

EXPERIMENTAL

Participants in this arm will receive personalized nutritional counseling sessions aimed at improving their dietary habits, attitudes, and overall health outcomes. The counseling will take place over a 8-week period, and participants will undergo assessments before and after the intervention to evaluate changes in anthropometric measurements, body composition, and various health metrics.

Behavioral: Nutritional Counseling

Interventions

Nutritional Counseling BEHAVIORAL

The intervention involves nutritional counseling aimed at improving dietary habits and overall health to participants. During the 2-month period, participants will receive guidance on nutrition, diet planning, and lifestyle changes tailored to their needs. Assessments of knowledge, attitudes, and health metrics will be conducted before and after the counseling sessions to measure the effectiveness of the intervention

Nutritional Counseling Group

Eligibility Criteria

• Age: 24 Years - 63 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female employees at Adam Malik Hospital, Medan
• Participants aged \<65 years
• Participants with a Body Mass Index (BMI) ≥25 kg/m²
• Participants who are willing to follow all stages of the research procedure and sign the informed consent

You may not qualify if:

• Pregnant or breastfeeding women with infants under 1 year of age
• Participants undergoing routine treatment with insulin, corticosteroids, antipsychotics, antiepileptics, or beta-blockers
• Participants unable to undergo body composition measurement

Sponsors & Collaborators

• RS H Adam Malik: lead

Study Sites (1)

Nutrition Unit of Adam Malik Hospital

Medan, North Sumatera, 20136, Indonesia

Location

MeSH Terms

Conditions

Obesity

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Hilna K Shalihat, Master's

  Indonesian Association of Clinical Nutrition Specialists

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Nutrition Unit

Model Details: This study is a quasi-experimental design with a single group of participants receiving nutritional counseling. The participants will undergo pre- and post-intervention assessments to measure changes in health indicators, attitudes, and behaviors.

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: October 1, 2024
• Study Start: August 26, 2024
• Primary Completion: October 25, 2024
• Study Completion: November 25, 2024
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)